Astria Therapeutics Announces ALPHA-ORBIT Phase 3 Trial Design for Navenibart in Hereditary Angioedema

Astria Therapeutics, Inc., a leading biopharmaceutical company specializing in therapies for allergic and immunologic diseases, has announced the design of its ALPHA-ORBIT Phase 3 clinical trial for navenibart, targeting hereditary angioedema (HAE). This pivotal trial is set to begin in Q1 2025, with top-line results anticipated in early 2027.

The ALPHA-ORBIT trial aims to evaluate the efficacy and safety of navenibart using flexible dosing options: every 3 months (Q3M) and every 6 months (Q6M). Designed with input from global regulatory authorities, including the European Medicines Agency and the U.S. Food and Drug Administration (FDA), the trial underscores Astria’s commitment to patient-centric approaches in HAE treatment.

Astria’s ALPHA-ORBIT program, supported by these promising results, is designed to secure global registration for navenibart. Aiming to redefine HAE treatment, the company anticipates bringing this life-changing therapy to market.